Teach you to diagnose five freeze-dried problems

The freeze-dried product should have good physical form, no defect in appearance, flat surface, the volume is basically equal to the volume when frozen, the color is uniform, the interior is loose and porous, the rehydration is rapid and complete, the residual moisture content is qualified, and the titer is high. Can be stored for a long time.

1. When the product is pumped out, there is a spray phenomenon: this is because the product has not been vacuumed in real time, the pre-freezing temperature is not lower than the eutectic point temperature, or has been lower than the eutectic point temperature, but the time is not enough, the product is frozen. Not completed yet. The solution is to reduce the pre-freezing temperature and extend the pre-freezing time.

2. The product has shrinkage and bubbling phenomenon: this is due to the partial melting during the sublimation drying process, which evaporates into a vapor body, which causes the volume to shrink, or the dry product dissolves into the liquid, resulting in a volume reduction and a serious melting. Bubbling occurs because the heating is too high or the partial vacuum is poor to cause the product temperature to exceed the eutectic point or the disintegration point temperature. The solution is to lower the heating temperature and increase the vacuum of the lyophilizer. The temperature of the product should be controlled so that it is 5 °C below the eutectic point or disintegration point.

3. No fixed shape: This is due to too little dry matter in the product, the product concentration is too low, no skeleton is formed, and even the dried product is carried by the sublimation vapor stream to the outside of the container. The solution is to increase the product concentration or add excipients.

4. The product is not finished: the frozen ice is finished when the frozen ice is present in the product. After the container is released, the frozen part is melted into a liquid. A small amount of liquid is sucked away by the dried product to form a “vacancy”. When the liquid volume is large, the dried product is completely Dissolved into the liquid to become a concentrated liquid. If the product touches the bottom of the container when it is out of the box, it has a cold feeling. Even if the product looks good, the residual water content will not be qualified. The solution is to increase the heat supply, increase the temperature of the sheet or use vacuum adjustment, or it may not be enough drying time, and it is necessary to extend the time of sublimation drying or desorption drying.

5. Product color is not uniform: the product has a crystal pattern, which is caused by the slow freezing rate. The solution is to increase the freezing rate and not stay at the temperature of 0 °C left to freeze the product into smaller crystals. Sometimes a layer of darker layered lines can be seen in the product, which is often caused by poor vacuum in the short-term sublimation. This phenomenon occurs with short pauses.

Bed Head Unit For Ward

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